Pathological GamblingNCT00211822
Functional Magnetic Resonance Imaging (fMRI) Studies in Pathological Gambling (PG) and Obsessive-Compulsive Disorder (OCD)
An observational study of Pathological Gambling and Obsessive Compulsive Disorder, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
This study will explore the brain processes associated with inhibition and reward processing in pathological gamblers and people with obsessive compulsive disorder compared to healthy controls. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pathological Gambling, Obsessive Compulsive Disorder
- What is being tested?
- fMRI
- Type of treatment
- Surgery or procedure
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to Dec 2010
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: community sample
Who may be able to join
- Male or female adults diagnosed with pathological gambling or obsessive compulsive disorder aged 18-55.
- Subject has signed an informed consent form
- Must provide contact information
- Must be in generally good health
- Must be willing and able to read written instructions and complete scales
- Must be English speaking
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- In the opinion of the investigator, the subject is capable of complying with all study procedures
- Pathological Gamblers only:
- Current diagnosis of pathological gambling, supported by DSM-IV SCI-PG
- Must score ≥ 5 on SOGS
- Must score ≥ 2 on item number 1 on the G-SAS
- Subjects must have a severity score of ≥ 4 (moderately ill) on the Clinical Global Impressions Scale - Severity (CGI-S)
- Must score ≥ 10 on questions 1-5 on PG-Y-BOCS
- Must score ≤ 15 on YMRS
- Must have gambled once within past 2 weeks of Screening Visit.
Who cannot join
- Subjects with a primary diagnosis of schizophrenia, personality disorder, or other psychotic disorders
- Subjects with a primary diagnosis of an Axis I disorder that may require intervention
- Must not score >24 on the Montgomery-Asberg Depression Rating Scale (MADRS) (pathological gamblers only)
- Subjects who live in a restrictive environment
- Subjects with a current DSM-IV diagnosis of substance dependence or abuse, excluding nicotine
- Subjects reporting a history of drug and/or alcohol dependence or abuse; subjects who report occasional drug use in the past will be discussed by a panel (consisting of Dr. Gilbert, Dr. Fan and Dr. Bartz), and will be considered for participation on a case by case basis
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- Subjects who have used psychotropic medications in the past week to six weeks (depending on the medication)
- Subject has a positive drug urine screen
- Female subjects who are pregnant
- Subjects who report a history of severe liver, heart, or kidney disease because these conditions are associated with neurological sequella
- Employees of the investigator or study center or their families
- Finally, subjects who do not satisfy the following criteria will be excluded because they will be unable to undergo the MRI procedure. Specifically, subjects will be excluded who have:
- a pacemaker
- any implanted metallic chips in their head
- ever worked around a metal lathe or had a shrapnel (war or gun shot) wound/injury
- an implanted neuro-stimulatory or infusion/insulin pump
- any devices placed in their blood vessels
- any metal in/on their body
- kidney disease
- sickle-cell or hemolytic anemia
- claustrophobia
- any metallic tattoos
- any body piercing that cannot be removed
- dental braces
- any permanent make-up
- any cardiac stints
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai School of Medicine
New York, New York, 10029
About this study
Official title: fMRI Studies in Pathological Gambling and Obsessive-Compulsive Disorder
This study will explore the brain processes associated with inhibition and reward processing in pathological gamblers and people with obsessive compulsive disorder compared to healthy controls.
Read the detailed description
This study will explore the brain processes associated with inhibition and reward processing in pathological gamblers and people with obsessive compulsive disorder compared to healthy controls. Healthy participants and participants who are diagnosed with PG or OCD will undergo one fMRI scan. The brain scan will last about one and a half hours and will involve performing tasks while in the scanner.
- Being tested
- fMRI
- Keywords
- Pathological Gambling, Obsessive-Compulsive Disorder, Go No-go, Monetary incentives delay, fMRI
- Medical subject headings
- Gambling, Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRIProcedure or surgery
fMRI
| Study group | Role | What they receive |
|---|---|---|
| Pathologic Gamblers | Not described Receives: Procedure: fMRI | |
| Obsessive Compulsive Disorder | Not described Receives: Procedure: fMRI | |
| Healthy Controls | Not described Receives: Procedure: fMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
fMRI - go-nogo task
a measure of behavioral response inhibition
Measured: at baseline
fMRI - monetary incentive delay (MID) task
a measure of neural response to anticipating and receiving monetary rewards
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startNov 2004
- Primary completionDec 2010
- Study completionDec 2010
Why it stopped: Enrollments closed after former PI Eric Hollander left institution. There are no results.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pathological GamblingStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Investigators
- Eric Hollander, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00211822
- Sponsor's protocol ID
- GCO#04-1034
- Status last verified
- Jul 2011
- First submitted
- 13 Sep 2005
- Last updated
- 14 Jul 2011
- Results posted
- No
- Data monitoring committee
- No